Advanced Sterilization Products (ASP) announced today that the French Health Products Safety Agency, AFSSAPS, will approve the low-temperature hydrogen peroxide gas plasma STERRAD® NX™ and the STERRAD® 100NX™ Sterilization Systems for total inactivation of prions.

Prions, which are protein-based infectious agents, cause neurodegenerative brain diseases characterized by the formation of “holes” in brain tissue. Prions are highly resistant to the commonly used procedures for inactivating them, and until recently, only the most severe sterilization processes had been proven effective.

“The effectiveness of low-temperature STERRAD® technology against the prion threat confirmed that is possible to eliminate these deadly pathogens while helping to preserve the integrity of medical devices, including heat sensitive surgical instruments,” said Dr. Pascal Clayette, SPI-BIO, CEA, Fontenay-aux-Roses, France. “This is a great milestone for healthcare facilities who use an increasing number of sophisticated and costly surgical instruments and for patients who demand the most stringent infection prevention practices.”

Following a number of in vivo and in vitro studies conducted on behalf of ASP by two independent laboratories in France and Germany, the STERRAD® NX™ Advanced Cycle and STERRAD® 100NX™ System Flex and Standard Cycles successfully provided prion inactivation and proved to be more effective on the prion threat than steam sterilization at 134degrees C for 18 minutes, which is the steam cycle recommended by the World Health Organization.

“The AFSSAPS approval of STERRAD® System sterilization technology for total inactivation of prions is another example of ASP’s commitment to developing innovative infection prevention solutions that help raise the standards of care,” said Chuck Austin, WW President of ASP. “STERRAD® Sterilization Systems are used by thousands of healthcare facilities across the globe and this new approval by the French Health Products Safety Agency is a significant benefit for customers and patients alike.”

Prion diseases, or proteinaceous infectious particle only agents, are able to induce abnormal folding of normal cellular prion proteins in the brain and can develop into neurodegenerative disorders including Gerstmann-Straussler-Scheinker Syndrome, fatal familial insomnia and Creutzfeldt-Jakob Disease (CJD) in humans. Such prion diseases can have long asymptomatic incubation periods but will result in fatality in all cases. Unlike infectious agents in other difficult-to-treat infectious diseases, prions exhibit an unusually high level of resistance to common sterilization methods and disinfection methods, including steam, and pose a threat to infection prevention in healthcare facilities.

About the Data

ASP, through the use of several independent laboratories in France and Germany produced a set of comprehensive studies on prion inactivation. 61 tests (41 in vivo and over 20 in vitro controls) evaluating and comparing disinfection, washing and sterilization procedures were performed. In these studies, the STERRAD® NX™ Advanced Cycle and STERRAD® 100NX™ System Flex and Standard Cycles proved to be more effective in prion inactivation than a steam cycle at 134degreesC, 18 minutes- a special optimized steam cycle recommended by the World Health Organization against prions.